Statement on the safety of the “conjugated linoleic acid (CLA) rich oils” Clarinol® and Tonalin® TG 80 as Novel Food ingredients

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to update its opinions on the safety of the conjugated linoleic acid (CLA)‐rich oils Clarinol® and Tonalin® TG 80 as Novel Food ingredients in the light of additional information provided by Member States to the European Commission. Clarinol® and Tonalin® TG 80 consist of approximately 80% of the two CLA isomers c‐9 , t‐11 and t‐10 c‐12 (1:1). The applicants suggested a daily intake of CLA of 3g (3.75g Clarinol®) and 3.5g (4.5g Tonalin® TG 80), respectively. The Panel considers that the additional information provided does not contain evidence thath would modify its previous conclusions regarding the effects of CLA on insulin sensitivity/glucose metabolism, blood lipids, lipid peroxidation, or subclinical inflammation. The Panel also considers that the new studies provided do not address longer‐term (> 6 months) effects of CLA intake on insulin sensitivity, the arterial wall or liver steatosis, or the safety of CLA in type‐2 diabetic subjects, under the proposed conditions of use. The Panel concludes that the safety of Clarinol® and Tonalin® TG 80 has been established for the proposed uses and daily doses for up to six months. The safety of CLA consumption for periods longer than six months has not been established under the proposed conditions of use. The safety of CLA consumption by type‐2 diabetic subjects has not been established.